Status:
UNKNOWN
Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Acute B Lymphoblastic Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
Comparing the efficacy and safety of fludarabine-containing BFC conditioning regimen with traditional BuCy conditioning regimen in Acute B-cell lymphoblastic leukemia patients who treated with allogen...
Detailed Description
This study was a prospective, randomized, controlled, single-center clinical study. A total of 142 patients eligible for the inclusion of acute B lymphoblastic leukemia were randomly divided into two ...
Eligibility Criteria
Inclusion
- Ages 18-55.
- The patient was diagnosed as acute B-lymphoblastic leukemia, which was confirmed by bone marrow cell morphology, cytochemistry, immunotyping and chromosome examination, including acute chronic myelocytic leukemia, Ph-acute B-lymphoblastic leukemia, and acute B-lymphoblastic leukemia after CART treatment.
- The diagnostic criteria for b-blastic leukemia in remission were: complete hematologic response (CR) with negative minimal residual lesions (MRD) after regular induction of remission chemotherapy, or complete hematologic response with negative MRD after CART treatment.
- ECOG physical fitness status score ≤2.
- All organs function normally and meet the following inspection standards:
- A) Liver function ALT, AST and TBIL≤2 times the upper limit of normal value B) BUN and Cr of renal function ≤1.25 times the upper limit of normal value.
- Have the following cardiac function conditions: ecg examination did not indicate any acute myocardial infarction, arrhythmia or atrioventricular block of degree I or above; Centerless incomplete function; No active rheumatic heart disease; There was no indication of cardiac enlargement on chest radiograph or physical examination.
- (7) The patient had a qualified allogeneic hematopoietic stem cell transplantation donor, including haploid, myeloma and sibling.
- 8\) The patient and its legal client have the desire and requirement for hematopoietic stem cell transplantation, and sign the informed consent, and are willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc.
- 9\) The donor meets the donation requirements-
Exclusion
- There are any contraindications for allogeneic hematopoietic stem cell transplantation.
- Ph+ acute lymphoblastic leukemia
- Serious damage of important organ functions, such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.
- Pregnant or lactating women.
- Those who are undergoing clinical trials of other drugs.
- Patients suffering from other serious acute or chronic physical or mental diseases, or abnormal laboratory examination, which may affect the administration of study drugs and the researchers' judgment of the condition and interpretation of the test results, are not suitable to participate in the clinical trial.
- The donor does not fit the conditions of the donor.
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05379569
Start Date
May 15 2022
End Date
December 30 2025
Last Update
May 18 2022
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, China